A global conglomerate in EMC testing, product safety, regulatory affairs, and certification has engaged JTL on a search for Medical Device Specialists (Auditors or Engineers).
We’re seeking an exceptional professional with ambition and an internal drive to progress in your science. In return, our client will provide for you a path to become an ISO13485 Medical Device Lead Auditor, Notified Body Auditor, & FDA 3rd party 510K reviewer. By completing this path, you’ll position yourself for a promotion in responsibilities and generous increase in financial compensation.
The “What”…Your Mission
As a Medical Device Specialist, your role and responsibilities include assessment of medical devices and their manufacturers per the European Medical Devices Directives and other applicable Regulatory Systems & International standards, including related client and project management.
As a Medical Device Specialist, you will be responsible for the following:
- Performing audits of clients per European Medical Device Directives (AIMD, MDD, IVDD) and International quality system standards (e.g. ISO 9000, ISO 13485), as well as internal MHS division and Company criteria. These audits include all related tasks such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission at the certification committee.
- Acting as Test Engineer and Technical Certifier for Company by inspecting and testing products for conformity with international regulations to produce the end result of certificate of conformance for the client.
- Preparing reports and documentation for certification of customer products to the appropriate standards. Performing Constructional Review, Testing, and Preliminary Evaluations activities
- Providing project management for NAFTA-based customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client inquiries.
- Interacting with sales and marketing to initiate business, conducting informational meetings with prospective clients, following up on leads, and generating quotes. In this capacity, you’ll showcase your technical expertise by providing information to the client to communicate the company’s full-range of services and products.
- Courteously and effectively communicating with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.
- Keeping abreast of present and pending MHS tools, regulatory requirements, standards and Company Engineering service capabilities through internal training sessions, external seminars, and reading of technical articles.
Thriving Medical Device Specialists in this role typically possess the following:
- BS or MS Degree in a science related field (biotechnology, biology, chemistry, microbiology, electrical engineering, mechanical engineering, etc.)
- Significant industrial medical device experience e.g. as Product Designer / Product Development Scientist / Project Manager / Microbiologist / Sterilization Specialist / Engineer / Regulatory Affairs / Quality Assurance.
- A minimum of 5 years of experience in an industrial medical device environment with 2 of those years spent in Quality.
- Direct auditing experience (Medical Device Directives AIMD, MDD, CMDR, JGMP, IVD, ISO 13485:2003) and Lead Auditor Certification is beneficial.
- Bilingual ability in German or Spanish language is a plus.
- Desire and availability for 70-80% local, domestic and occasional international travel (generally Monday-Friday).
Our pioneering client is offering immediate opportunities in its Northwest, Northeast, & California locations. Relocation benefits and assistance are offered for selected candidates.
*The opportunity to work from a home office may be considered for an exceptional and fully qualified candidate as defined by this position overview and interview.
And best of all… The “WHY”
Compensation and Quality of Life
Show Me the Money!
As a new Medical Device Specialist, your financial package will consist of a competitive base salary (dependent on credentials and experience) and a 10-15% annual bonus structure based on company and personal performance. You will be paid bi-weekly via direct deposit.
You will be eligible to participate in the Company’s 401k program wherein you’ll enjoy a 50% Company match of the first 6% of your salary that you contribute to your plan.
You will also have access to the Company Flexible Spending Plan which allows you to pay for qualified expenses (i.e. Dependent Care and/or Health expenses not covered by insurance, Group Term Life, and Outside Health Insurance) using pre-tax dollars. For all of the dollars you elect towards your Flex plan, you’ll save yourself the expense of Social Security, State, and Federal taxes. Under this plan, you may choose to reclassify salary as tax-free reimbursement of certain qualified expenses. As a result, you may receive a portion of pay on a tax-free basis.
Can I Have a Life, Too?
Yes, you CAN be successful here and still have a life! In appreciation for your service, you’ll enjoy generous paid time off:
- 17 personal choice days within your 1st year;
- 8 paid holidays designated by the Company;
- 2 additional floating holidays of your own designation!
- Jury Duty Leave, Uniformed Service Leave & unpaid personal leave of absence available as applicable.
What if I Don’t Want to be a Medical Device Specialist Forever?
We don’t expect you to! This Medical Device Specialist opportunity provides a path to become an ISO13485 Medical Device Lead Auditor, Notified Body Auditor, & FDA 3rd party 510K reviewer. By completing this path, you’ll position yourself for a promotion in responsibilities and generous increase in financial compensation.
If you have additional educational interests, the Company will invest in your future by offering tuition assistance to aid you in furthering your education after two years of service.
Everything Sounds Great-but What About Insurance?
Health, dental, life, disability…you name it; we’ve got you covered!
- Blue Cross/Blue Shield PPO Health Insurance Plan
- Delta Dental Plan
- 100% Company-paid Life Insurance
- 100% Company-paid Short-term Disability Insurance
- 100% Company-paid Long-term Disability Insurance